A new ketamine-based nasal spray that promises to help adults who suffer from treatment-resistant depression has been approved by the American Food and Drug Administration (FDA).
The treatment, called esketamine, is a fast-acting drug derived from ketamine, a generic anaesthetic. It is commonly used as a party drug called Special K.
Esketamine, developed by Belguim-based Janssen Pharmaceuticals, will be sold under the name Spravato. Unlike the drugs traditionally used to treat depression, esketamine has the potential to work within hours, instead of weeks or even months.
The New York Times reports doctors welcomed the FDA approval but were concerned about the cost and long-term effects of the drug. Among their concerns are that ketamine’s antidepressant properties are not yet well understood. Another is both ketamine and esketamine can induce psychotic episodes in people who are at high risk of them.
According to a FDA News Release, using Spravato can lead to “risk of serious adverse outcomes resulting from sedation and dissociation … and the potential for abuse and misuse of the drug.”
Because of these safety concerns, the new treatment will be made available through a restricted distribution system and will have to be administered by a medical practitioner in a doctor’s office or clinic, where the patient can be monitored. Furthermore, the patient must have been unable to find relief through at least two other medications and the treatment must be used in conjunction with oral antidepressants.
Apart from the above risks to the patient, one month of treatment will hit their pocket hard at between $4 720 and $6 785 (about R67 000 and R97 000).
According to Tiffany Farchione, acting director of the Division of Psychiatry Products in the FDA's Center for Drug Evaluation and Research, treatment-resistant depression is a serious and life-threatening condition and there has long been a need for effective treatments for it.
She says, "Controlled clinical trials that studied the safety and efficacy of this drug, along with careful review through the FDA’s drug approval process including a robust discussion with our external advisory committees, were important to our decision to approve this treatment.”
For sufferers of long-term, treatment-resistant depression this might be the helping hand they’ve been waiting for. Whether it is worth the risks and the cost remains to be seen.
New nasal spray to treat depression approved
A new ketamine-based nasal spray that promises to help adults who suffer from treatment-resistant depression has been approved by the American Food and Drug Administration (FDA).
The treatment, called esketamine, is a fast-acting drug derived from ketamine, a generic anaesthetic. It is commonly used as a party drug called Special K.
Esketamine, developed by Belguim-based Janssen Pharmaceuticals, will be sold under the name Spravato. Unlike the drugs traditionally used to treat depression, esketamine has the potential to work within hours, instead of weeks or even months.
The New York Times reports doctors welcomed the FDA approval but were concerned about the cost and long-term effects of the drug. Among their concerns are that ketamine’s antidepressant properties are not yet well understood. Another is both ketamine and esketamine can induce psychotic episodes in people who are at high risk of them.
According to a FDA News Release, using Spravato can lead to “risk of serious adverse outcomes resulting from sedation and dissociation … and the potential for abuse and misuse of the drug.”
Because of these safety concerns, the new treatment will be made available through a restricted distribution system and will have to be administered by a medical practitioner in a doctor’s office or clinic, where the patient can be monitored. Furthermore, the patient must have been unable to find relief through at least two other medications and the treatment must be used in conjunction with oral antidepressants.
Apart from the above risks to the patient, one month of treatment will hit their pocket hard at between $4 720 and $6 785 (about R67 000 and R97 000).
According to Tiffany Farchione, acting director of the Division of Psychiatry Products in the FDA's Center for Drug Evaluation and Research, treatment-resistant depression is a serious and life-threatening condition and there has long been a need for effective treatments for it.
She says, "Controlled clinical trials that studied the safety and efficacy of this drug, along with careful review through the FDA’s drug approval process including a robust discussion with our external advisory committees, were important to our decision to approve this treatment.”
For sufferers of long-term, treatment-resistant depression this might be the helping hand they’ve been waiting for. Whether it is worth the risks and the cost remains to be seen.